non-notified medical devices

INDIA OFFICIALLY REQUIRES REGISTRATION OF ALL NON-NOTIFIED DEVICES

Voluntary Phase

On February 11th, 2020 the Ministry of Health and Family Welfare published the Medical Device Rules, 2020 as an amendment to the Medical Device Rules, 2017 providing for the voluntary registration of all non-Notified medical devices over a 18-month period with the Central Drugs Standard Control Organization (CDSCO). These Medical Device Rules, 2020 will come into full effect on April 1, 2020.

Mandatory Phase

After the voluntary period (i.e., from October 1, 2021) all class A and B devices would have 16 months to be registered (i.e., by Sep 1, 2022) in the CDSCO’s on-line portal. Class C and D devices would have 24 months to meet the same requirement (i.e., by September 1, 2023).

Registration Process

The truncated registration application involves administrative documents such a Free Sales Certificate from the country of origin, ISO 13485 certificate, as well as basic product information. The registration process carries no government processing fees and does not expire, but may be cancelled or suspended by the CDSCO for product safety concerns, or when superseded by the requirement for an Import License (upon Notification). Once registered the local license holder will be required to notify the CDSCO and Materiovigilance Programme of India (MvPi) of Serious Adverse Events (SEA) occurring in India.

Manufacturers of non-Notified medical devices are advised to evaluate their products of interest for India and begin to build their application files for a Registration Certificate.

We can help

Asia Actual is available to answer questions or help register your devices when the new requirements take effect. Contact us to arrange an initial conversation.